Gulf War Illness Clinical Trial
Official title:
Exercise in Gulf War Illness (GWI)
Verified date | August 2019 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine if submaximal exercise by bicycle stress tests with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets).
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 38 Years to 86 Years |
Eligibility |
Inclusion Criteria: - Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to: - Persian Gulf waters and adjacent land areas - Other global locations - U.S. only - Status prior to 1990 and 1991: - Active duty - National Guard - Reserves Exclusion Criteria: - Current active duty military personnel - Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991 - HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests. Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested |
Country | Name | City | State |
---|---|---|---|
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | U.S. Army Medical Research and Development Command |
United States,
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. — View Citation
Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51. — View Citation
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. — View Citation
Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302. — View Citation
Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Köppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. — View Citation
Rayhan RU, Ravindran MK, Baraniuk JN. Migraine in gulf war illness and chronic fatigue syndrome: prevalence, potential mechanisms, and evaluation. Front Physiol. 2013 Jul 24;4:181. doi: 10.3389/fphys.2013.00181. eCollection 2013. — View Citation
Rayhan RU, Stevens BW, Raksit MP, Ripple JA, Timbol CR, Adewuyi O, VanMeter JW, Baraniuk JN. Exercise challenge in Gulf War Illness reveals two subgroups with altered brain structure and function. PLoS One. 2013 Jun 14;8(6):e63903. doi: 10.1371/journal.po — View Citation
Rayhan RU, Stevens BW, Timbol CR, Adewuyi O, Walitt B, VanMeter JW, Baraniuk JN. Increased brain white matter axial diffusivity associated with fatigue, pain and hyperalgesia in Gulf War illness. PLoS One. 2013;8(3):e58493. doi: 10.1371/journal.pone.00584 — View Citation
Rayhan RU, Zheng Y, Uddin E, Timbol C, Adewuyi O, Baraniuk JN. Administer and collect medical questionnaires with Google documents: a simple, safe, and free system. Appl Med Inform. 2013;33(3):12-21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the alterations due to exercise in Gulf War Veterans | Difference in duration of exercise between first and second submaximal bicycle exercise stress test | 02/2009-09/2012 |
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